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Anti-T Lymphocyte Immunoglobulin For Human Use, Pig

This article discusses a clinical trial investigating the use of Anti-T Lymphocyte Immunoglobulin for Human Use, Pig (also known as LIS1) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The study aims to assess the safety, tolerability, and effectiveness of this new treatment option for patients who have not responded well to previous therapies. The trial is divided into two parts: a dose escalation phase to determine the optimal dose and a dose expansion phase to further evaluate the drug’s efficacy in selected PTCL types.

Table of Contents

What is LIS1?

LIS1 is a new medication being studied for the treatment of certain blood cancers. Its full name is “ANTI-T LYMPHOCYTE IMMUNOGLOBULIN FOR HUMAN USE, PIG,” but it’s referred to as LIS1 for short. This drug is a type of glyco-humanized polyclonal antibody, which means it’s a complex mixture of antibodies that have been modified to work better in the human body[1].

Target Condition: Peripheral T-Cell Lymphoma (PTCL)

LIS1 is being developed to treat a group of blood cancers called Peripheral T-Cell Lymphoma (PTCL). PTCL is a rare and aggressive type of cancer that affects a specific kind of white blood cell called T-cells. These cells are an important part of your immune system, but when they become cancerous, they can cause serious health problems[1].

How LIS1 Works

LIS1 is designed to target and attack cancerous T-cells in the body. It’s an immunotherapy, which means it works with your immune system to fight cancer. The antibodies in LIS1 are specifically created to recognize and attach to harmful T-cells, potentially helping to destroy them or stop them from growing[1].

Clinical Trial Overview

LIS1 is currently being studied in a clinical trial to determine if it’s safe and effective for patients with PTCL. This trial is divided into two parts[1]:

  1. Part 1 (Dose Escalation): This phase aims to find the right dose of LIS1 that is both safe and effective. Researchers will carefully monitor patients for any side effects and how well the drug works at different doses.
  2. Part 2 (Dose Expansion): Once the best dose is determined, more patients will be given LIS1 to further study its effectiveness and safety.

Potential Benefits of LIS1

While the effectiveness of LIS1 is still being studied, researchers hope it may offer several benefits for patients with PTCL[1]:

  • Potentially shrink or slow the growth of tumors
  • Possibly improve survival rates for patients with this aggressive cancer
  • May provide a new treatment option for patients who have not responded well to other therapies
  • Could potentially help some patients become eligible for stem cell transplantation, which is a more definitive treatment for some blood cancers

Eligibility Criteria

Not all patients with PTCL will be eligible for this clinical trial. Some key eligibility criteria include[1]:

  • Age 18 or older
  • Diagnosed with specific types of PTCL that have not responded to previous treatments or have come back after treatment
  • Generally good overall health, with adequate organ function
  • No active infections or other cancers

Safety Considerations

As with any new medication, there are potential risks and side effects associated with LIS1. The clinical trial is designed to carefully monitor patients for any adverse reactions. Some potential side effects that researchers will be watching for include[1]:

  • Infusion-related reactions
  • Changes in blood cell counts
  • Infections
  • Liver or kidney function changes

It’s important to note that not all patients will experience these side effects, and there may be other unforeseen reactions. The research team will closely monitor all participants and provide appropriate care.

Conclusion

LIS1 represents a promising new approach in the treatment of Peripheral T-Cell Lymphoma. While it’s still in the early stages of research, this medication could potentially offer new hope for patients with this challenging cancer. As the clinical trial progresses, more information will become available about the effectiveness and safety of LIS1[1].

Aspect Details
Study Type Phase I/II, open-label, multi-center clinical trial
Drug Name Anti-T Lymphocyte Immunoglobulin for Human Use, Pig (LIS1)
Target Condition Relapsed or refractory peripheral T-cell lymphoma (PTCL)
Study Design Two parts: Dose Escalation (Part 1) and Dose Expansion (Part 2)
Primary Objectives Assess safety, tolerability, and efficacy; Identify maximum tolerated dose and recommended Phase II dose
Key Eligibility Criteria Adults with confirmed PTCL, prior treatment history, measurable disease
Administration Method Intravenous infusion
Key Outcomes Measured Safety profile, objective response rate, duration of response, survival metrics

FAQ

  • What is Anti-T Lymphocyte Immunoglobulin for Human Use, Pig (LIS1)? LIS1 is a glyco-humanized polyclonal antibody directed against tumoral T cells. It's being studied as a potential treatment for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who haven't responded well to previous treatments.
  • What is the main goal of this clinical trial? The main goal is to evaluate the safety and efficacy of LIS1 in patients with relapsed or refractory PTCL. This includes determining the optimal dose, assessing side effects, and measuring how well the drug works against the cancer.
  • Who is eligible to participate in this trial? Eligible participants are adults (18 years or older) with a confirmed diagnosis of relapsed or refractory PTCL who have previously received at least one appropriate systemic therapy. They must also meet specific health criteria and have measurable disease.
  • How is the drug administered in this trial? LIS1 is administered through intravenous infusion, which means it's given directly into the bloodstream through a vein.
  • What are some of the key outcomes being measured in this trial? Key outcomes include the incidence of side effects, changes in laboratory values, objective response rate (how many patients see their cancer shrink or disappear), duration of response, time to response, progression-free survival, and overall survival.

Ongoing Clinical Trials on Anti-T Lymphocyte Immunoglobulin For Human Use, Pig

  • Study on the Safety and Effectiveness of LIS1 for Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)

    Recruiting

    1 1
    Investigated drugs:
    France Italy

Glossary

  • Peripheral T-cell lymphoma (PTCL): A group of aggressive blood cancers that develop from mature T cells, a type of white blood cell important for immune function.
  • Relapsed/Refractory: Relapsed means the cancer has returned after treatment. Refractory means the cancer has not responded to treatment or has stopped responding.
  • Polyclonal antibody: A mixture of antibodies that recognize and bind to many different parts of a target, such as cancer cells.
  • Dose Escalation: A process in clinical trials where the dose of a drug is gradually increased to find the optimal balance between effectiveness and side effects.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.
  • Recommended Phase II Dose (RP2D): The dose determined to be safe and potentially effective, which is then used in further studies.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Objective Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • Complete Response (CR): The disappearance of all signs of cancer in response to treatment.
  • Partial Response (PR): A decrease in the size of a tumor or in the extent of cancer in the body in response to treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-lis1-for-patients-with-relapsed-or-refractory-peripheral-t-cell-lymphoma-ptcl/